Recall Z-1946-2015— Axis-Shield Diagnostics, Ltd.
Class II · Terminated
Class II FDA medical device recall by Axis-Shield Diagnostics, Ltd., initiated 2015-03-20, terminated 2015-10-27. It names one FDA 510(k) clearance: K083222. Product: Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.. Reason: Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery..
- Recalling firm
- Axis-Shield Diagnostics, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-20
- Terminated
- 2015-10-27
- Firm location
- Dundee, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.
Reason for recall
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
Data sourced from openFDA. This site is unofficial and independent of the FDA.